Hypertension
Conditions
Brief summary
The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus
Interventions
DRUGMicardis®
DRUGMicardisPlus®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Hypertension * Diabetes mellitus
Exclusion criteria
* Age \< 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in systolic blood pressure (SBP) | Baseline, after 6 months |
| Change from Baseline in diastolic blood pressure (DBP) | Baseline, afterr 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of efficacy by investigator on a 6-point scale | after 6 months | — |
| Change from Baseline in laboratory parameters | Baseline, after 6 months | Metabolic parameters - Triglyceride, total cholesterol, blood glucose and HbA1c |
| Assessment of tolerability by investigator on a 5-point scale | after 6 months | — |
| Assessment of metabolic effect on a 4-point scale | after 6 months | — |
| Number of patients with adverse events | up to 6 months | — |
Outcome results
None listed